Programme 2020

December 14-15, 2019; San Diego, CA

8:00 AM - 8:45 AM

Registration & Refreshments

8:45 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Small Molecules

Bespoke Dosing for Pediatric Patients

Rick Panicucci, Senior Vice President CMC, QED Therapeutics

  • Current clinical manufacturing utilize a “one size fits all” approach
  • For very young patients this is far from ideal
  • Personalized dosing based on weight of subject
  • One patient per batch

9:30 AM - 10:05 AM - Case Studies

Biologics

Accelerated Stability Testing of Biopharmaceutical Excipients

  • Accelerated vs Real-Time testing techniques
  • Humidity and pH accelerated effects prediction
  • Current regulations for accelerated shelf life assessments

Device Development

10:10 AM - 10:45 AM - Solution Spotlights

Small Molecules

Solution Spotlight Topic TBC (Quotient Sciences)

Device Development

Solution Spotlight Topic TBC (Datwyler)

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Device Development

How to use Smart Devices Intelligently to Deliver Outcomes

Jace Blackburn, Smart Device Engineer, Genentech

  • Introduction to Smart Devices
    • Types of Smart Devices & data they generate
    • Current Smart Device applications on the market
  • How to evaluate the fit of Smart Devices with a brand team’s digital strategy
    • Strategies to dig into with your marketing colleagues
    • Strategies that should raise red flags
  • How to execute a make vs buy decision for companion applications to support your digital strategy
  • Delivering on the prioritized outcomes through the implementation of behavior design
    • Intro on behavior design
    • Analyzing reasons for medication non-adherence or non-persistence with a behavior design lens

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight Topic TBC (Foster Delivery Science)

Technology & Innovation

Solution Spotlight Topic TBC (Lonza)

12:50 PM - 1:50 PM

Networking Lunch

Lunch & Learn Round Table with MedPharm



Lunch & Learn Round Table with W.L. Gore

1:35 PM - 2:10 PM - Case Studies

Device Development

Topic TBC (Genentech)

2:15 PM - 2:50 PM - Solution Spotlights

Device Development

Solution Spotlight Topic TBC (Sonceboz)

Small Molecules

Solution Spotlight Topic TBC (Cydex Pharmaceuticals)

2:50 PM - 3:40 PM

iSolve & Networking Break

3:40 PM - 4:55 PM - Case Studies

Small Molecules

Impact of Bile Salts on Solubilization and Membrane Transport of Supersaturated Drug Formulations

Helen Hao Hou, Senior Scientist Small Molecule Pharmaceutical Sciences , Genentech

Technology & Innovation

Innovations in Creating Drugs for CNS Diseases

5:00 PM - 5:30 PM - Panel Discussion

Device Development

Preparing for Patient-Centric Drug Development Regulations

  • What do the recent FDA Guidelines on Patient-Focused Drug Development (PFDD) mean to us?
  • Why do we need more patient focussed thinking and design of drug products, medical devices and combination products? How will become more patient focussed shake up the industry and make us more competitive

5:30 PM - 5:35 PM

Chair’s Closing Remarks

5:35 PM - 6:35 PM

Drinks Reception

8:00 AM - 8:45 AM

Registration & Refreshments

8:45 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Biologics

Novel CART Cell Therapy Based Tumour Treatments

  • Challenges and solutions to finding correct antigens
  • Overcoming hostile environment associated with tumours

9:30 AM - 10:05 AM - Case Studies

Technology & Innovation

Challenges and Strategies in Formulation Development and Manufacture of High Concentration Biotherapeutics

Kevin Zen, Executive Director, Analytical Characterization, Formulation Development, and Biologics Manufacture, Anaptys bio

Subcutaneous (SC) injection of biotherapeutics has become a valuable alternative to intravenous administration across many disease areas. Most SC administration requires higher concentration of biotherapeutics. This poses unique challenges to drug delivery, formulation development, and manufacture in order to meet final product specifications and shelf life. Typically the high protein concentration challenges include solubility, opalescence, viscosity, particulate formation, protein aggregation and stability. In this talk, such challenges will be reviewed and addressed by real-world examples.

Biologics

Liquid Preformulation Assessment of Biological Candidates

Shwetha Iyer, Senior Scientist- Formulation and Characterization , Novartis

Abstract TBC

10:10 AM - 10:45 AM - Solution Spotlights

Technology & Innovation

Solution Spotlight Topic TBC (Nanoform)

Device Development

Solution Spotlight Topic TBC (Sensile Medical)

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

Optimizing Conventional Formulations for Continuous Manufacturing

  • Improving material science, API and process robustness for continuous manufacturing
  • Ensuring you have fully automated controls to realize true end-to-end pharma production
  • Breakthrough technologies poised to revolutionize formulation and manufacturing

Biologics

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight Topic TBC (PMC Isochem)

Technology & Innovation

Solution Spotlight (Session TBC)

Abstract TBC

12:50 PM - 1:50 PM

Networking Lunch

1:35 PM - 2:10 PM - Case Studies

Small Molecules

Achieving better Success Rate at Developing CNS Targeted Drugs

  • How to overcome the stumbling block of pharmacokinetics/pharmacodynamics
  • Choosing more efficient dosages

Biologics

QbD and Process Scale Up Considerations

  • Biological continuous manufacturing
  • Making sense of regulatory guidelines
  • Formulating drugs with manufacturing in mind

2:15 PM - 2:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight (Session TBC)

Biologics

Solution Spotlight (Session TBC)

2:50 PM - 3:40 PM

Networking Break

3:40 PM - 4:55 PM - Case Studies

Technology & Innovation

Nanoparticles for targeted Tumour Drug Delivery

  • Improving stability of microparticle internalised chemotherapy
  • Potential to minimise systemic toxicity with new formulations

Biologics

Antibody-Drug Conjugates Formulation, Stabilisation

  • Formulating monoclonal antibody and the payload in unison
  • Improving characterisation and control of newer ADCs
  • Potential for hydrophobic drugs

5:00 PM - 5:30 PM - Panel Discussion

Device Development

What does the Future Hold for Novel Drug Delivery and Combination Products?

  • What are the current and anticipated hurdles to novel drug delivery?
  • What are the current biggest challenges to developing new combination products and how will this affect LCM?
  • How will new technology change current products (special focus on apps and connectivity)

5:30 PM - 5:35 PM

Poster Presentation Award

5:35 PM - 5:40 PM

Chair’s Closing Remarks